suzhou, july 30, 2020 - alphamab oncology (stock code: 9966.hk) announced that jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab” or “alphamab oncology”), a wholly-owned subsidiary of the company, has entered a partnership agreement with kintor pharmaceutical limited (“kintor pharmaceutical” , stock code 9939.hk), to jointly develop the combination therapy of pd-l1 / ctla-4 bispecific antibody kn046 and alk-1 monoclonal antibody gt90001 in hepatocellular carcinoma (hcc).
liver cancer is the fourth most common cancer in china and the second leading cause of death by cancer. the most common type of liver cancer is hepatocellular carcinoma (hcc). despite the development of various new therapies, the overall survival rate of patients is still low. there is an urgent need for better treatment options to benefit patients. this collaboration will explore the safety, tolerability, and efficacy of the combination therapy of kn046 and gt90001 for malignant tumors such as liver cancer. according to the agreement, alphamab oncology and kintor pharmaceutical will establish a joint-development committee to jointly finance their cooperation on pre-clinical development, ind application, clinical development and registration for the hcc combination therapy and other indications agreed by both parties.
dr. ting xu, founder, chairman and ceo of alphamab oncology commented, “kn046 is a recombinant humanized pd-l1/ctla-4 bispecific antibody invented by alphamab, with the potential to become the next generation immuno-oncology therapy. alphamab oncology is actively deploying kn046's combination therapy development strategy. currently, it has initiated 7 combination clinical trials. the indications include hepatocellular carcinoma, pancreatic cancer, her-2 positive or expressing solid tumors, and late stage non-small cell lung cancer. we look forward to successful cooperation with kintor pharmaceutical to further unlock the great value of kn046, the pd-l1 / ctla-4 bispecific antibody, and provide effective treatment options for liver cancer patients.
dr. youzhi tong, founder, chairman and ceo of kintor pharmaceutical commented, "gt90001 (alk-1 antibody) is considered as a potential ‘first-in-class’ drug in-licensed from pfizer. the clinical trial data of the combination therapy of gt90001 and immunotherapy for the treatment of liver cancer led by professor chiun hsu from national taiwan university’s affiliated hospital in taiwan shows that it has good safety and anti-tumor activity. kintor pharmaceutical will focus on the alk-1 target by developing antibody biologics to achieve better clinical benefits through the inhibition of multiple signaling pathways, including 1) carry out the registration trial in the hcc second-line treatment with alk-1 and pd-1 combination therapy as soon as possible; 2) carry out the clinical study in the treatment of other solid tumors with alk-1 and pd-1 combination therapy; 3) explore new treatments of solid tumors with combination of alk-1 and other immunotherapeutic bispecific antibodies. this cooperation with alphamab oncology is an important step in this direction. we hope to provide more treatment choices for liver cancer patients.”
kn046 is the world's first recombinant humanized pd-l1/ctla-4 bispecific invented by alphamab. its innovative designs include: a proprietary ctla-4 domain antibody with a significantly improved safety profile; a bispecific antibody fused with pd-l1 antibody; engineered to target the tumor microenvironment with high pd-l1 expression, and treg clearing function. the preclinical and clinical study results of kn046 have shown promising efficacy and significantly reduced toxicity to human peripheral system, with the potential to become the breakthrough immuno-oncology therapy.
previously, kn046's phase i clinical trials in australia and china have shown a preliminary profile of good safety and promising efficacy, and several phase ii clinical trials are ongoing in china for nsclc, tnbc, escc and pancreatic cancer. us fda has approved kn046 to enter phase ii trial based on the clinical results in china and australia.
gt90001 is alk-1 (“activin receptor-like kinase-1”), an antagonistic mediator of lateral transforming growth factor-beta/alk-5 signaling, which is a fully humanized igg2 neutralizing monoclonal antibody. kintor entered into a license agreement with pfizer on alk-1 in 2018, pursuant to which we obtained an exclusive global license to develop, manufacture and commercialize alk-1 for treatment of cancer. alk-1 binds to its ligands bmp9 and bmp10, regulates smad, the fusion of caenorhabditis elegans sma genes and the drosophila mad family of genes, phosphorylation, and promotes stable vascular maturation. alk-1 can inhibit the growth of tumor vessels and reduce their blood flow and vascularization by blocking the receptors, thereby slowing down the development of tumors. as a first-in-class compound, alk-1 has the potential to become the first fully human monoclonal antibody therapeutic drug for the treatment of a variety of solid tumors.
pfizer has completed two phase i clinical trials, one in the united states and italy and the
other in south korea and japan, for alk-1 for over 100 patients with advanced solid tumors, of which a favorable safety and preliminary validity profile was demonstrated. currently gt90001 is in phase ii clinical trials carried out by kintor pharmaceutical in taiwan as a combination therapy with nivolumab, a pd-1, for metastatic hcc (hepatocellular carcinoma).
about alphamab oncology
alphamab oncology is a biopharmaceutical company focusing on innovative biologics medicine in oncology. on december 12, 2019, the company was listed in the mainboard of hong kong stock exchange with stock code 9966.
alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into phase i – iii clinical development phases in china, us and japan.
the company also has state-of-the-art manufacturing capability designed and built to meet nmpa and eu/fda’s cgmp standards. alphamab oncology is committed to further develop its robust pipeline in oncology/immunology to benefit patients around the world.
visit http://www.alphamabonc.com for more information.
about kintor pharmaceutical limited
founded in 2009, kintor pharmaceuticals concentrates on the r&d and industrialization of “best-in-class” and “first-in-class” innovative drugs, and strives to become a leading enterprise in the r&d and commercialization of innovative therapies.
the company was founded by national-level talents, after years of development, centered upon androgen receptor (ar) related diseases and researched and developed product portfolios in multiple channels covering cancers with a globally high incidence and illnesses yet to meet their clinical requirements, such as prostate cancer, breast cancer, liver cancer and hair loss. kintor pharmaceuticals has prospectively deployed a diversified product pipeline that includes small molecule innovative drugs, bio-innovative drugs and combination therapies, including 5 products that are undergoing clinically researched androgen receptor antagonists, alk-1 monoclonal antibody, mtor kinase inhibitors and hedgehog inhibitors, as well as ar-degrader, c-myc inhibitors and ido inhibitors that are undergoing preclinical research.
globally, the company owns more than 60 patents obtained or under review, many of which are listed as the “major new drugs discovery” in national 12th and 13th five-year plans. on 22 may 2020, the company was officially listed on the hong kong stock exchange with the stock code 9939.hk.
visit http://www.kintor.com.cn for more information.
alphamab oncology forward-looking statements
this press release contains statements related to our future business and financial performance and future events or developments involving alphamab oncology that may constitute forward-looking statements. these statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. these statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. we may also make forward-looking statements in other reports, in presentations, in material delivered to shareholders and in press releases. in addition, our representatives may from time to time make oral forward-looking statements. such statements are based on the current expectations and certain assumptions of alphamab oncology’s management and business operation, many of which are difficult to predict and generally beyond alphamab oncology’s control. these are subject to a number of risks and uncertainties, including but not limited to, uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, alphamab oncology's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding and alphamab oncology’s disclosures. should one or more of these risks or uncertainties materialize, or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of alphamab oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statement. other than as required by applicable law, alphamab oncology undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.